The biggest story to come out of the American Heart Association’s annual jamboree is undoubtedly the JUPITER randomised controlled trial, which was showcased on Monday to a packed auditorium of over 6000 cardiologists. Data from the trial suggest that even healthy people with low cholesterol may benefit from receiving rosuvastatin to prevent cardiac events, if they have high levels of high-sensitivity C-reactive protein.
The trial was due to run for 4 years, but was stopped prematurely in March after just 2 years when an interim analysis showed that patients who received rosuvastatin were approximately half as likely to have a coronary event compared with those who received placebo. The trial’s independent data and safety monitoring board decided that it would be unethical to continue giving some people placebo in light of this strong evidence of efficacy, so they voted to stop the trial.
Reducing the risk by half sounds very impressive, and many people will call for statins to be prescribed more widely as a result of JUPITER, but some cardiologists (including Mark Hlatky, who wrote an excellent editorial in the NEJM about the trial) quite rightly say that caution is needed. For the trial illustrates how important it is to make the distinction between relative and absolute risk before drawing conclusions about a study’s clinical relevance.
Closer inspection of the data reveals that 157 of the 8901 (1.9%) people who received placebo had a cardiac event compared with 83 of the 8901 (0.9%) who received rosuvastatin. So, although the relative risk reduction was about 50%, the reduction in absolute risk was only 1%. Put another way, doctors will have to treat 120 people for 2 years to prevent one cardiac event.
Since the drug costs $3.45 per day, would prescribing it to apparently healthy people be a good use of resources? (Spending ~$300k to prevent one cardiac event would be hard to justify.) It’s quite possible that generic statins, which are much cheaper than rosuvastatin, could be similarly beneficial, but I’d hazard a guess that AstraZeneca will be using the results from JUPITER to convince doctors that Crestor is the best one to prescribe. Indeed, the coffers of The New England Journal of Medicine, which published the trial, are likely to be bulging soon as highly lucrative reprint orders start to flood in.
Read Nature News‘s briefing on the trial results.
James Butcher is publisher of Nature’s eight Clinical Practice review journals.